Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia

Pfizer

Status and phase: Completed; Phase 4

Conditions: Community-Acquired Pneumonia (CAP)

Treatments: Drug: ceftriaxone; Drug: IV azithromycin; Drug: oral azithromycin; Drug: oral levofloxacin; Drug: IV levofloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035347

A0661035

Details and patient eligibility

About

A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens.

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must be 18 years or older.
• Patient must be hospitalized and require intravenous therapy for treatment of pneumonia.
• Patient must have pneumonia as documented by relevant signs and symptoms and a positive chest X-ray.
• Patients cannot have certain underlying diseases or conditions as defined in the study protocol.

Exclusion criteria

• Pregnant women, nursing mothers, or women of childbearing potential not practicing adequate contraception.
• Known or suspected hypersensitivity or intolerance to any quinolone, penicillin, cephalosporin, or macrolide antibiotic.
• Treatment with any systemic antibiotic for 24 hours or longer within 72 hours prior to the baseline visit.
• Subjects with clinically significant renal dysfunction.
• Subjects with clinically significant hepatic dysfunction.
• Subjects with clinically significant cardiovascular disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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219 participants in 2 patient groups

Azithromycin plus ceftriaxone group (AZY+CEF group)

Experimental group

Description:

IV azithromycin (500 mg once daily) plus ceftriaxone (1 gram once daily) for 2 to 5 days followed by oral azithromycin (2 x 250 mg once daily) to complete a total of 7 to 10 days of therapy

Treatment:

Drug: oral azithromycin

Drug: IV azithromycin

Drug: ceftriaxone

Levofloxacin group (LEV group)

Experimental group

Description:

IV levofloxacin (500 mg once daily) for a minimum of 2 days followed by oral levofloxacin (500 mg once daily) to complete a total of 7 to 14 days of therapy.

Treatment:

Drug: IV levofloxacin

Drug: oral levofloxacin